Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke. The HALTI Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Presence of new ischemic lesions
研究概览
简要总结
To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure.
详细描述
Young patients with a cryptogenic ischemic event undergoing transcatheter PFO closure exhibit a low but clinically relevant risk of bleeding (overall and major bleeding) at long-term follow-up, eventually exceeding the risk of ischemic events.
Importantly, the vast majority of major bleeding events seem to occur in patients receiving antiplatelet therapy. Preliminary data suggest that antiplatelet therapy discontinuation is not associated with any increase in ischemic events, and could potentially translate into a lower rate of major bleeding events at longer term follow-up. We therefore hypothesize that in young patients without any other comorbidities increasing the risk of stroke, shorter-term (≤1 year instead of lifelong) antiplatelet treatment could be a safe option following PFO closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Successful transcatheter PFO closure with any approved device
- •Patients ≤60 years diagnosed with a cryptogenic stroke/TIA who have undergone successful transcatheter PFO closure
排除标准
- •>60 year-old
- •RoPE score <6
- •Residual shunt ≥moderate following PFO closure
- •Atrial fibrillation following PFO closure
- •Presence of ≥2 cardiovascular risk factors (smoking, hypertension, dyslipidemia)
- •Diabetes mellitus
- •Thrombophilia (factor V Leiden, factor II mutation, anticardiolipin antibodies, lupus anticoagulant, anti-b2 glycoprotein-I antibodies, protein C deficiency, protein S deficiency)
- •Recurrent cerebrovascular event (stroke, TIA) within the year following PFO closure
- •Failure to provide signed informed consent
- •Absolute contraindications for an MRI study
结局指标
主要结局
Presence of new ischemic lesions
时间窗: 24-month follow-up
Evaluated by MRI
Presence of new stroke events
时间窗: 12 months
1)Acute episode of a focal or global neurological deficit with at least one of the following: change in level of consciousness, hemiplegia, hemiparesis, numbness or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopia, amaurosis fugax or other new neurological symptom(s) consistent with stroke.(2)Duration of a focal or global neurological deficit ≥ 24 hours OR \< 24 hours if available neuroimaging documents a new hemorrhage or infarct; OR the neurological deficit results in death.
次要结局
- Number of new cerebral ischemic lesions(24-month follow-up)
- Rate of bleeding(10-year follow-up)
- Volume of new cerebral ischemic lesions(24-month follow-up)
- Number of ischemic events(10-year follow-up)
- Number of ischemic events(24-month follow-up)
- Number of ischemic events(3-year follow-up)
- Number of ischemic events(4-year follow-up)
- Number of ischemic events(5-year follow-up)
- Number of ischemic events(6-year follow-up)
- Number of ischemic events(7-year follow-up)
- Number of ischemic events(8-year follow-up)
- Number of ischemic events(9-year follow-up)
- Rate of bleeding(24-month follow-up)
- Rate of bleeding(3-year follow-up)
- Rate of bleeding(4-year follow-up)
- Rate of bleeding(5-year follow-up)
- Rate of bleeding(6-year follow-up)
- Rate of bleeding(7-year follow-up)
- Rate of bleeding(8-year follow-up)
- Rate of bleeding(9-year follow-up)
研究者
Josep Rodes-Cabau
Principal Investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval